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Food and Drug Administration Press Releases
Press releases from FDA
FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid
The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution.
FDA Approves New Drug to Treat Severe Form of Epilepsy
The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome.
FDA Warns Public of Extortion Scam by FDA Impersonators
The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.
FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.
FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.
FDA Approves Toviaz, a New Drug to Treat Overactive Bladder
The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB.
HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Pa...
Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.
FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.
FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Un...
The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
FDA Approves Lung Valve to Control Some Air Leaks after Surgery
The U.S. Food and Drug Administration today approved an implantable and removable valve system designed to control some air leaks in the lungs that persist after certain kinds of lung surgery.
FDA Approves Updated Labeling for Psoriasis Drug Raptiva
The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.
FDA Creates Web Page with Drug Safety Information for Patients, Health Care P...
Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs
FDA Licenses for Marketing New Therapy for Rare Genetic Disease
The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States.
FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostat...
The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.
FDA Launches Food Defense Awareness Training Kit for Employees in the Food In...
Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table.